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The eQuinox Oxygen System is intended for the administration of supplemental oxygen. The eQuinox Oxygen System is prescription legend required.

The eQuinox Oxygen System is an oxygen concentrator that provides continuous flow or in pulse mode, an oxygen bolus. The eQuinox Oxygen System is based on pressure swing adsorption (PSA) principles. The eQuinox Oxygen System operates from AC power, or rechargeable batteries. This device delivers supplemental oxygen for patients through the molecular sieve beds and is designed to conserve the use of oxygen while operating in pulse flow mode. During pulse flow mode, oxygen is delivered to the patient through a pulse flow valve when the start of inhalation is detected. The eQuinox Oxygen System consists of pneumatic and electrical components, AC power supply, DC cable and lithium ion batteries. The system has inlet filtration, air compressor, and Synthetic Zeolite molecular sieve beds with a rotary valves, outlet filtration, electronic flow control and audible / visual alarms.

This document is a 510(k) summary for the eQuinox Oxygen System, which is an oxygen concentrator. The device is being submitted for substantial equivalence to previously marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document explicitly states that "Performance testing demonstrates that the eQuinox Oxygen System is compliant with ISO 8359 standard for Oxygen Concentrators." This standard would contain the detailed acceptance criteria which are summarized in the table above based on the comparative data provided. The specific numerical values for oxygen concentration (90 ± 3%) are presented as the device's technical specifications and implicitly serve as the acceptance criteria for the purpose of demonstrating substantial equivalence to the predicate devices.

2. Sample size used for the test set and the data provenance:

• Sample Size: The document does not specify a distinct sample size for a "test set" in the context of typical clinical evaluations. The performance data discussed relates to the device's inherent functional characteristics (e.g., oxygen concentration, electrical safety). It's implied that various units of the eQuinox Oxygen System were tested to confirm these specifications.
• Data Provenance: The data is primarily from in-house performance testing conducted by the manufacturer, Chart SeQual Technologies Inc. The document does not mention data from external clinical studies or specific countries of origin for the data. The testing is retrospective in the sense that it was performed on pre-manufactured devices to verify their compliance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not provided in the document. The performance data relates to objective physical and electrical measurements of the device's function, not interpretations by medical experts.

4. Adjudication method for the test set:

• This information is not provided as the performance testing involves objective measurements against established engineering and medical device standards (ISO 8359, IEC 60601-1, IEC 60601-1-2), rather than subjective interpretations requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No, an MRMC comparative effectiveness study was not done. This device is an oxygen concentrator, not an AI-powered diagnostic tool requiring human interpretation enhancements.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• This question is not applicable as the device is hardware-based for oxygen delivery and does not involve an algorithm for diagnostic or interpretative purposes.

7. The type of ground truth used:

• The "ground truth" for the performance data is based on objective measurements against established international standards for oxygen concentrators (ISO 8359), electrical safety (IEC 60601-1), and electromagnetic compatibility (IEC 60601-1-2). For example, a gas analyzer would be used to objectively measure oxygen concentration, and electrical testing equipment would measure power consumption and safety parameters.

8. The sample size for the training set:

• This information is not applicable. The eQuinox Oxygen System is a physical medical device, not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established:

• This information is not applicable as there is no training set for this type of device.

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The Caire Spirit 300 will provide a source of supplemental oxygen for ambulatory healthcare patients by vaporizing medical grade liquid oxygen and then dispensing it to the patient via an integral electronic conserving device (digital oxygen conserving device-DOCD). The Spirit 300 is neither a life sustaining nor life supporting device.

The spirit 300 is a small, lightweight, liquid oxygen portable unit. The unit consists of a vacuum insulated cryogenic dewar, a vaporizer coil, an economizer regulator, two pressure relief valves, a manifold, an electronic printed circuit board conserving device (digital) and a protective case. The dewar has a capacity and capability to store 0.3L of liquid oxygen. The economizer regulator either draws gas from the dewar head space, if the internal pressure is above 20 PSI. If the internal pressure is below the 20 PSI, the economizer regulator will draw liquid oxygen, from the bottom of the dewar, which must then have to pass through a long vaporizing coil. The economizer regulator assures a longer duration time for the unit, because it allows the gas in the dewar headspace to be used for oxygen delivery. The gas outlet of the economizer regulator connects with the manifold, dependent on the flow selection setting, the manifold either delivers the gas to the conserving device PCB or diverts a 2L PM continuous flow directly to the oxygen outlet. The continuous flow setting is labeled CF on the flow selector. The conserving device has equivalent settings for 1, 1.5, 2, 3, 4 and 5 LPM prescriptions. At the various conserving device settings, the outlet gas is delivered in quick pulse dosage just at the onset of patient inhalation. The amount of gas delivered (with each breath) is approximately 15 ml/LPM setting.

This document is a 510(k) summary for the Caire Inc. Spirit 300 Portable Liquid Oxygen Unit. It describes the device, its indications for use, and confirms that modifications have not altered the fundamental scientific technology of the predicate device.

Based on the provided text, there is no acceptance criteria or study information that describes device performance in the way requested. This document is a regulatory submission summary for substantial equivalence, not a detailed technical report of performance testing against specific acceptance criteria.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment.

Here's why:

• Type of Document: This is a 510(k) summary, primarily focused on demonstrating "substantial equivalence" to a predicate device for regulatory approval. It asserts that modifications haven't altered fundamental technology, but it doesn't present the detailed test results or the specific acceptance criteria for those tests.
• Focus on Equivalence: The core of a 510(k) is to show that a new device is as safe and effective as a legally marketed predicate device. This is often done by comparing technical characteristics and demonstrating that any differences don't raise new questions of safety or effectiveness. It's not typically about proving performance against a novel set of clinical acceptance criteria with detailed study results as one might find for a PMA or CE Mark submission.

The document states: "Caire Inc confirms that the modifications described here within have not altered the fundamental scientific technology of the predicate device (Spirit 300) cleared under 510(K) number K013251." This is the primary "proof" offered in this summary, not a new study.

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The Spirit 300 HAS will provide a source of supplemental oxygen for ambulatory home healthcare patients, by vaporizing 93% liquid oxygen and then dispensing it to the patient via an integral electronic conserving device. The Spirit 300 HAS is intended to be transfilled only by the In-X Corporation's Home-Away System. The Spirit 300 HAS is neither a life sustaining nor life supporting device.

The Spirit 300 HAS is a small, lightweight, liquid oxygen portable unit. The unit consists of a vacuum-insulated cryogenic dewar, a vaporizer coil, an economizer regulator, two pressure safety relief valves, a manifold, an electronic printed circuit board conserving device and a protective case. The dewar has a capacity and capability to store 0.3 liters of liquid oxygen. The vaporizer coil warms the oxygen gas to a suitable temperature, as it exits the dewar. Dependant on the flow selection setting, the manifold either delivers the gas to the conserving device PCB or delivers a 2 LPM continuous flow directly to the oxygen outlet. The continuous flow setting is labeled CF on the flow selector. The conserving device has equivalent setting for 1, 1.5, 2, 3, 4, and 5 LPM prescriptions. At the various conserving device settings, the outlet gas is delivered in quick pulse dosages just at the onset of patient inhalation. The amount of gas delivered (with each breath) is approximately 15 ml/LPM setting. The Spirit 300 HAS is filled from a concentrator liquefaction device.

The provided text is a 510(k) summary for the Spirit 300 HAS Portable Liquid Oxygen Unit. It describes the device and its intended use, but it does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

The document is a regulatory submission for premarket notification, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance criteria and validation study results in detail. While device performance in terms of flow settings is mentioned in the device description, specific acceptance criteria for these performances and the studies validating them are not provided in this summary.

Therefore, I cannot fulfill the request for information on acceptance criteria and the study that proves the device meets them based on the provided text.

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The CAIRE Spirit 300 will provide a source of supplemental oxygen for ambulatory home healthcare patients, by vaporizing medical grade liquid oxygen and then dispensing it to the patient via an integral electronic conserving device. The Spirit 300 is neither a life sustaining nor life supporting device.

The Spirit 300 is a small, lightweight, liquid oxygen portable unit. The unit consists of a vacuuminsulated cryogenic dewar, a vaporizer coil, an economizer regulator, two pressure safety relief valves, a manifold, an electronic printed circuit board conserving device and a protective case. The dewar has a capacity and capability to store 0.3 liters of liquid oxygen. The vaporizer coil warms the oxygen gas to a suitable temperature, as it exits the dewar. The economizer regulator riams the ony gas from the dewar head space, if the internal pressure is above 20 PSI. If the internal pressure is below 20 PSI, the economizer regulator will draw liquid oxygen from the bottom of the dewar, which must then have to pass through a long vaporizing coil. The economizer regulator assures a longer duration time for the unit, because it allows the gas in the dewar head regulator be used for oxygen delivery. The gas outlet of the economizer regulator connects with the manifold. Dependant on the flow selection setting, the manifold either delivers the gas to the the manifolial Deportually diverts a 2 LPM continuos flow directly to the oxygen outlet. The continuos flow setting is labeled CF on the flow selector. The conserving device has equivalent settings for 1, 1.5, 2, 3, 4 and 5 LPM prescriptions. At the various conserving device settings, the outlet gas is delivered in quick pulse dosages just at the onset of patient inhalation. The amount of gas delivered (with each breath) is approximately 15 ml/LPM setting.

This document describes a 510(k) premarket notification for the CAIRE Spirit 300, a portable liquid oxygen unit. However, the provided text does not contain acceptance criteria or a study that proves the device meets specific performance metrics in the way you've outlined.

The document primarily focuses on establishing substantial equivalence to predicate devices (CAIRE Stroller, Puritan Bennett HELiOS, DeVilbiss LP05PP) based on technological characteristics and non-clinical testing. It states that the Spirit 300 "oxygenates similarly" to the predicate devices.

Therefore, I cannot provide the requested information in the format because the data is not present in the provided text.

Here's why and what information is available:

• Acceptance Criteria and Reported Device Performance: This information is typically found in performance testing reports, which are not included here. The document only generically states "non-clinical testing clearly shows that the Spirit 300 oxygenates similarly" to predicate devices. It notes slight differences, such as the Spirit 300 being "more sensitive" and oxygenating "a little better at the higher flow settings" than the DeVilbiss product.
• Sample Size (test set) and Data Provenance: Not specified. "Non-clinical testing" is mentioned, but no details on the number or type of tests, or the origin of any data, are provided.
• Number of Experts and Qualifications: Not specified. This typically relates to ground truth establishment for diagnostic or interpretive devices, which the Spirit 300 is not.
• Adjudication Method: Not applicable or specified.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This type of study is for diagnostic devices where human readers interpret results, often with AI assistance. The Spirit 300 is an oxygen delivery device.
• Standalone (algorithm only) performance: Not applicable. This device is not an algorithm, but a physical medical device.
• Type of ground truth used: Not applicable in the context of diagnostic performance. For a device like this, performance would be measured against engineering specifications (e.g., oxygen flow rate, concentration, duration).
• Sample size for the training set: Not applicable. This device does not use a training set in the context of AI/ML.
• How the ground truth for the training set was established: Not applicable.

Summary of available information related to performance/equivalence:

• Description of the Device: The Spirit 300 is a small, lightweight liquid oxygen portable unit with a vacuum-insulated cryogenic dewar, vaporizer coil, economizer regulator, pressure safety relief valves, manifold, electronic printed circuit board conserving device, and protective case. It has a 0.3-liter liquid oxygen capacity.
• Intended Use: Provides supplemental oxygen for ambulatory home healthcare patients by vaporizing medical grade liquid oxygen and dispensing it via an integral electronic conserving device. It is not a life-sustaining or life-supporting device.
• Technological Characteristics vs. Predicate Devices:
  • CAIRE Stroller: Spirit 300 has an integral electronic conserving device (delivers doses with patient inhalation) vs. Stroller's continuous flow. Spirit 300 is smaller/lighter. Dewar design, plumbing, fill connectors, relief valves, and vent valves are similar. Non-clinical testing showed similar oxygenation.
  • Puritan-Bennett HELiOS: Spirit 300 has an integral electronic conserving device vs. HELiOS's pneumatic conserving device. Otherwise, similar. Non-clinical testing showed similar (or significantly better) oxygenation.
  • DeVilbiss #LP05PP: Similar technical operation of conserving devices. Spirit 300 is 0.34L capacity vs. DeVilbiss 0.49L. Non-clinical testing showed similar oxygenation, with Spirit 300 being more sensitive and oxygenating "a little better at the higher flow settings."

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